Cosmetic compositions

ABSTRACT

Disclosed is a method for moisturizing skin in need thereof, the method comprising topically applying to the skin a composition that includes effective amounts of an extract from  Echinacea purpurea , an extract from  Silybum marianum , and glycerin, wherein topical application of the composition activates human cannabinoid receptor type 2 and inhibits fatty acid amide hydrolase activity in the skin and treats the skin.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/155,540, filed Oct. 9, 2018, which is a continuation of U.S. patentapplication Ser. No. 15/091,741 (U.S. Pat. No. 10,111,919) filed Apr. 6,2016, which is a continuation of U.S. patent application Ser. No.14/202,840 (U.S. Pat. No. 9,333,230) filed Mar. 10, 2014, which claimsthe benefit of U.S. Provisional Application No. 61/816,286 filed Apr.26, 2013 and U.S. Provisional Application No. 61/784,564 filed Mar. 14,2013. The contents of the referenced applications are incorporated intothe present application by reference.

BACKGROUND OF THE INVENTION A. Field of the Invention

The present invention generally relates to methods and compositionsuseful for treating skin conditions. More specifically, the presentinvention concerns topical skin care compositions that include anextract from Echinacea purpurea, an extract from Silybum marianum,glycerin, and/or a mixture comprising cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols andmethods of treating pruritic, dry, or erythemic skin with suchcompositions.

B. Description of Related Art

Pruritus or itch is defined as an unpleasant sensation of the skin thatprovokes the urge to scratch. It may be localized or generalized and canoccur as an acute or chronic condition. Itching can be intractable andincapacitating, as well as a diagnostic and therapeutic challenge. Theunderlying cause of this sensation is due to the activity of nervefibers in the epidermis and upper layers of the dermis. Dry skin, forexample, can activate these nerve fibers, which can induce the feelingof itchy skin, which is oftentimes followed by scratching. Scratching,however, can lead to skin irritation or erythema, spreading of existingskin conditions (e.g., dry skin such as seborrhoeic dermatitis, atopiceczema, contact dermatitis, or xerotic eczema), and an overall unsightlyor visually unpleasing appearance of the skin. Dry skin can even lead tofine lines and wrinkles.

Compositions that address the symptoms of pruritus are known. However,such compositions fail to treat both the pruritic skin and treating thecause of pruritic skin.

SUMMARY OF THE INVENTION

The inventor has discovered that a combination of ingredients can beused in a topical skin formulation as an antipruritic while alsotreating an underlying cause of pruritic/itchy skin (e.g., dry skin). Inthis sense, the combination can be said to have a dual effect: (1)treating pruritic skin; and (2) treating the cause of pruritic skin,which can be dry skin. The benefit of this dual effect is that only onecomposition is needed to effectively treat and prevent pruritic skin anddry skin. “Dry skin” or “xeroderma” includes skin that has reducedmoisture (when compared with normal skin), which can result in pruriticskin, skin having flakes (“flaky skin”), skin having scales (“scalyskin”), or skin having cracks. Examples of dry skin include seborrhoeicdermatitis, atopic eczema, contact dermatitis, or xerotic eczema.

In one embodiment, there is disclosed a composition comprising anextract from Echinacea purpurea, an extract from Silybum marianum,glycerin, and/or a mixture comprising cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols. In someembodiments, the topical skin care composition comprising adermatologically acceptable vehicle and a combination of the followingingredients: an Echinacea purpurea extract, a Silybum marianum extract,glycerin, and a mixture comprising cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols. In someembodiments, the composition activates human cannabinoid receptor type 2and/or inhibits fatty acid amide hydrolase activity in the skin.

The extract from Echinacea purpurea and/or the extract from Silybummarianum may be an aqueous, alcoholic, hydro-alcoholic, or oil-basedextract. In some embodiments, the Echinacea purpurea extract is anaqueous extract. In some embodiments, the Silybum marianum extract is anaqueous extract. The extract from Echinacea purpurea and/or the extractfrom Silybum marianum can be from the whole plant, leaf, seed, flower,stem, or root. In some embodiments, the Echinacea purpurea extract isfrom the whole plant. In some embodiments, the Silybum marianum extractis from the fruit.

The composition can further include a moisturization agent, a UVabsorbing agent, anti-oxidant, structuring agent, emulsifier, siliconecontaining compound, essential oil, thickening agent, and/or apreservative, such as those disclosed throughout this specification. Thecomposition can include a pharmaceutical ingredient, such as thosedisclosed throughout this specification. The composition can include0.0001 to 10% by weight (or 0.001, 0.01, 0.1, 1, 2, 3, 4, 5, 6, 8, 9, or10% by weight or more) of Echinacea purpurea extract, 0.0001 to 10% byweight of Silybum marianum extract (or 0.001, 0.01, 0.1, 1, 2, 3, 4, 5,6, 8, 9, or 10% by weight or more), 0.0001 to 10% by weight of glycerin(or 0.001, 0.01, 0.1, 1, 2, 3, 4, 5, 6, 8, 9, or 10% by weight or more),and/or 0.0001 to 10% by weight of a mixture comprisingcetylhydroxyproline palmitamide/steric acid/Brassica campestris(rapeseed) sterols (or 0.001, 0.01, 0.1, 1, 2, 3, 4, 5, 6, 8, 9, or 10%by weight or more). In some embodiments, the composition includes about0.50% by weight of the Echinacea purpurea extract, about 1.0% by weightof the Silybum marianum extract, and about 2.0% by weight of the mixturecomprising cetylhydroxyproline palmitamide/steric acid/Brassicacampestris (rapeseed) sterols. In some embodiments, the compositionincludes 15% by weight of glycerin.

Also disclosed is a method of treating pruritus comprising topicallyapplying to skin in need of treatment any one of the compositionsdisclosed throughout this specification, wherein topical application toskin in need of treatment treats pruritus. Pruritus, or itching, isdefined as an unpleasant sensation that provokes the desire to scratch.It can be associated with a number of disorders, including but notlimited to dry skin and erythemic skin. In addition to treatingpruritus, the composition can also simultaneously treat dry skin. Inanother embodiment there is disclosed a method of reducing the symptomsassociated with pruritus comprising topically applying to skin in needthereof any one of the compositions disclosed throughout thisspecification, wherein topical application of said compositions reducesthe symptoms associated with pruritus. The composition can be applied topruitic skin, erythemic skin, or dry skin. In some instances, thecompositions of the present invention can be used to treat fine linesand wrinkles by topically applying said compositions to fine linesand/or wrinkles.

In certain aspects, the composition is applied to the skin and remainson the skin for at least 5, 10, 15, 30, or more minutes, or 1, 4, 8, 12,16, 20, or 24 hours after topical application. The composition can beapplied to pruitic skin, erythemic skin or dry skin or seborrhoeicdermatitis that is present on facial skin, leg skin, ankle skin, armskin, hand skin, and/or scalp skin.

Also disclosed is a method of treating or reducing the symptoms ofpruritus comprising topically applying to pruritic skin a compositioncomprising: (a) an Echinacea purpurea extract and a Silybum marianumextract, wherein the combination of said extracts activates humancannabinoid receptor type 2 and inhibits fatty acid amide hydrolaseactivity in said pruritic skin; and (b) glycerin and a mixturecomprising cetylhydroxyproline palmitamide/steric acid/Brassicacampestris (rapeseed) sterols, wherein the combination of glycerin andthe mixture comprising cetylhydroxyproline palmitamide/stericacid/Brassica campestris (rapeseed) sterols moisturizes said pruriticskin.

The compositions of the present invention can be formulated into topicalskin care compositions. The compositions can be cosmetic compositions.In other aspects, the compositions can be included in a cosmeticvehicle. Non-limiting examples of cosmetic vehicles are disclosed inother sections of this specification and are known to those of skill inthe art. Examples of cosmetic vehicles include emulsions (e.g.,oil-in-water and water-in-oil emulsions), creams, lotions, solutions(e.g., aqueous or hydro-alcoholic solutions), anhydrous bases (e.g.,lipstick or a powder), gels, and ointments. In certain aspects, thecomposition can be formulated as a cream, gel, or lotion. In someinstances, the composition is an emulsion (e.g., oil-in-water,water-in-oil, hydrophilic-in-hydrophobic, hydrophobic-in-hydrophilic,silicone-in-water, water-in-silicone, etc.).

The compositions can also be formulated for topical skin application atleast 1, 2, 3, 4, 5, 6, 7, or more times a day during use. In otheraspects of the present invention, compositions can be storage stable orcolor stable, or both. It is also contemplated that the viscosity of thecomposition can be selected to achieve a desired result (e.g., dependingon the type of composition desired, the viscosity of such compositioncan be from about 1 cps to well over 1 million cps or any range orinteger derivable therein (e.g., 2 cps, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30,40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900,1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10000, 20000,30000, 40000, 50000, 60000, 70000, 80000, 90000, 100000, 200000, 300000,400000, 500000, 600000, 700000, 800000, 900000, 1000000 cps, etc., asmeasured on a Brookfield Viscometer using a TC spindle at 2.5 rpm at 25°C.). The compositions in non-limiting aspects can have a pH of about 6to about 9. In other aspects, the pH can be 1, 2, 3, 4, 5, 6, 7, 8, 9,10, 11, 12, 13, or 14. Compositions of the present invention can haveUVA and UVB absorption properties. The compositions can have an sunprotection factor (SPF) of 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 20, 25, 30, 35, 40, 45, 50, 55, 60, or more, or any integer orderivative therein. The compositions can be sunscreen lotions, sprays,or creams. In particular aspects, the compositions can be oil-free,substantially anhydrous, and/or anhydrous. Other aspects includecompositions having water.

The compositions of the present invention can also include any one of,any combination of, or all of the following additional ingredients:water, a chelating agent, a moisturizing agent, a preservative, athickening agent, a silicone containing compound, an essential oil, astructuring agent, a vitamin, a pharmaceutical ingredient, or anantioxidant, or any combination of such ingredients or mixtures of suchingredients. In certain aspects, the composition can include at leasttwo, three, four, five, six, seven, eight, nine, ten, or all of theseadditional ingredients identified in the previous sentence. Non-limitingexamples of these additional ingredients are identified throughout thisspecification and are incorporated into this section by reference. Theamounts of such ingredients can range from 0.0001% to 99.9% by weight orvolume of the composition, or any integer or range in between asdisclosed in other sections of this specification, which areincorporated into this paragraph by reference.

Additionally, the compositions can also be used to treat or prevent avariety of other skin conditions. For instance, the compositions can beused to treat or prevent a fine line or wrinkle, erythema, sensitiveskin, or inflamed skin. In particular aspects, erythema, sensitive skin,or inflamed skin is caused by skin sunburn, electrical treatments ofskin, skin burns, contact allergies, systemic allergies, skin toxicity,exercise, insect stings, bacterial infection, viral infection, fungalinfection, protozoa infection, massage, or windburn. In other aspects,the following additional skin conditions can be treated or prevented inaccordance with the methods and compositions disclosed throughout thespecification and claims: pruritus, lentigo, spider veins, age spots,senile purpura, keratosis, melasma, blotches, nodules, sun damaged skin,dermatitis (including, but not limited to seborrheic dermatitis,nummular dermatitis, contact dermatitis, atopic dermatitis, exfoliativedermatitis, perioral dermatitis, and stasis dermatitis), psoriasis,folliculitis, rosacea, acne, impetigo, erysipelas, erythrasma, eczema,and other inflammatory skin conditions. In certain non-limiting aspects,the skin condition can be caused by exposure to UV light, age,irradiation, chronic sun exposure, environmental pollutants, airpollution, wind, cold, heat, chemicals, disease pathologies, smoking, orlack of nutrition. The skin can be facial skin or non-facial skin (e.g.,arms, legs, hands, chest, back, feet, etc.). The method can furthercomprise identifying a person in need of skin treatment. The person canbe a male or female. The age of the person can be at least 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75,80, 85, 90, 95, or more years old, or any range derivable therein. Themethod can also include topically applying an amount effective to:increase the stratum corneum turnover rate of the skin; increasecollagen synthesis in fibroblasts; increase cellular anti-oxidantdefense mechanisms (e.g., exogenous additions of anti-oxidants canbolster, replenish, or prevent the loss of cellular antioxidants such ascatalase and glutathione in skin cells (e.g., keratinocytes,melanocytes, langerhans cells, etc.) which will reduce or preventoxidative damage to the skin, cellular, proteins, and lipids); inhibitmelanin production in melanocytes; reduce or prevent oxidative damage toskin (including reducing the amount lipid peroxides and/or proteinoxidation in the skin).

Also contemplated are kits that include any one of the compositionsdisclosed throughout the specification and claims. In certainembodiments, the composition is comprised in a container. The containercan be a bottle, dispenser, or package. The container can dispense apre-determined amount of the composition. In certain aspects, thecompositions is dispensed in a spray, dollop, or liquid. The containercan include indicia on its surface. The indicia can be a word, anabbreviation, a picture, or a symbol.

Also contemplated is a product comprising a composition of the presentinvention. In non-limiting aspects, the product can be a cosmeticproduct. The cosmetic product can be those described in other sectionsof this specification or those known to a person of skill in the art.Non-limiting examples of products include a moisturizer, a cream, alotion, a skin softener, a foundation, a night cream, a lipstick, acleanser, a toner, a sunscreen, a mask, or an anti-aging product.

Also disclosed are the following Embodiments 1 to 33 of the presentinvention. Embodiment 1 is a method for treating pruritus comprisingtopically applying a composition that includes an effective amount of anEchinacea purpurea extract, a Silybum marianum extract, glycerin, and amixture comprising cetylhydroxyproline palmitamide/steric acid/Brassicacampestris (rapeseed) sterols to skin in need thereof, wherein topicalapplication of the composition treats pruritus. Embodiment 2 is themethod of method Embodiment 1, wherein the composition activates humancannabinoid receptor type 2 and inhibits fatty acid amide hydrolaseactivity in the skin. Embodiment 3 is the method of any one ofEmbodiments 1 to 2, wherein the Echinacea purpurea extract is an aqueousextract. Embodiment 4 is the method of any one of Embodiments 1 to 3,wherein the Echinacea purpurea extract is from the whole plant.Embodiment 5 is the method of any one of Embodiments 1 to 4, wherein theSilybum marianum extract is an aqueous extract. Embodiment 6 is themethod of any one of Embodiments 1 to 5, wherein the Silybum marianumextract is from the fruit. Embodiment 7 is the method of any one ofEmbodiments 1 to 6, wherein the composition is formulated as a cream,lotion, emulsion, serum, or cleanser. Embodiment 8 is the method of anyone of Embodiments 1 to 7, wherein the composition is an oil to in towater emulsion or a water to in to oil emulsion. Embodiment 9 is themethod of any one of Embodiments 1 to 8, wherein an effective amount is0.001 to 10% by weight of the Echinacea purpurea extract, 0.001 to 10%by weight of the Silybum marianum extract, and 0.001 to 10% by weight ofthe mixture comprising cetylhydroxyproline palmitamide/stericacid/Brassica campestris (rapeseed) sterols. Embodiment 10 is the methodof Embodiment 9, wherein an effective amount is 0.50% by weight of theEchinacea purpurea extract, 1.0% by weight of the Silybum marianumextract, and 2.0% by weight of the mixture comprisingcetylhydroxyproline palmitamide/steric acid/Brassica campestris(rapeseed) sterols. Embodiment 11 is the method of Embodiment 10,wherein an effective amount is 15% by weight of glycerin. Embodiment 12is the method of any one of Embodiments 1 to 9, wherein the skin ispruritic skin, dry skin, or erythemic skin. Embodiment 13 is the methodof any one of Embodiments 1 to 12, wherein the composition is applied tothe skin and remains on the skin for at least 5 minutes after topicalapplication. Embodiment 14 is the method of any one of Embodiments 1 to13, wherein the skin in need of treatment is facial skin, leg skin,ankle skin, arm skin, hand skin, or scalp skin. Embodiment 15 is themethod of any one of Embodiments 1 to 14, wherein the compositionfurther comprises at least one of a moisturization agent, a UV absorbingagent, anti to oxidant, structuring agent, emulsifier, siliconecontaining compound, essential oil, thickening agent, and apreservative. Embodiment 16 is the method of any one of Embodiments 1 to15, wherein the composition further comprises a pharmaceuticalingredient. Embodiment 17 is a method for reducing the symptomsassociated with pruritus comprising topically applying a compositionthat includes an effective amount of an Echinacea purpurea extract, aSilybum marianum extract, and a mixture comprising cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols to skinin need thereof, wherein topical application of the composition reducesthe symptoms associated with pruritus. Embodiment 18 is a method oftreating pruritus comprising topically applying to pruritic skin acomposition comprising an Echinacea purpurea extract and a Silybummarianum extract, wherein the combination of said extracts activateshuman cannabinoid receptor type 2 and inhibits fatty acid amidehydrolase activity in said pruritic skin and glycerin and a mixturecomprising cetylhydroxyproline palmitamide/steric acid/Brassicacampestris (rapeseed) sterols, wherein the combination of glycerin andthe mixture comprising cetylhydroxyproline palmitamide/stericacid/Brassica campestris (rapeseed) sterols moisturizes said pruriticskin. Embodiment 19 is a topical skin care composition comprising adermatologically acceptable vehicle and a combination of the followingingredients: an Echinacea purpurea extract, a Silybum marianum extract,glycerin, and a mixture comprising cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols.Embodiment 20 is the topical skin care composition of Embodiment 19,wherein the Echinacea purpurea extract is an aqueous extract. Embodiment21 is the topical skin care composition of any one of Embodiments 19 to20, wherein the Echinacea purpurea extract is from the whole plant.Embodiment 22 is the topical skin care composition of any one ofEmbodiments 19 to 21, wherein the Silybum marianum extract is an aqueousextract. Embodiment 23 is the topical skin care composition of any oneof Embodiments 19 to 22, wherein the Silybum marianum extract is fromthe fruit. Embodiment 24 is the topical skin care composition of any oneof Embodiments 19 to 23, wherein the composition further comprises atleast one of a moisturization agent, a UV absorbing agent, anti tooxidant, structuring agent, emulsifier, silicone containing compound,essential oil, thickening agent, and a preservative. Embodiment 25 isthe topical skin care composition of any one of Embodiments 19 to 24,wherein the composition further comprises a pharmaceutical ingredient.Embodiment 26 is the topical skin care composition of any one ofEmbodiments 19 to 25, wherein the composition is formulated as a cream,lotion, gel, or serum. Embodiment 27 is the topical skin carecomposition of any one of Embodiments 19 to 26, wherein the compositionis an oil to in to water or water to in to oil emulsion. Embodiment 28is the topical skin care composition of any one of Embodiments 19 to 27,wherein the composition includes 0.001 to 10% by weight of eachingredient or a combination of ingredients. Embodiment 29 is the methodof Embodiment 28, wherein an effective amount is 0.50% by weight of theEchinacea purpurea extract, 1.0% by weight of the Silybum marianumextract, and 2.0% by weight of the mixture comprisingcetylhydroxyproline palmitamide/steric acid/Brassica campestris(rapeseed) sterols. Embodiment 30 is the method of Embodiment 29,wherein an effective amount is 15% by weight of glycerin. Embodiment 31is the topical skin care composition of any one of Embodiments 19 to 28,wherein the composition activates human cannabinoid receptor type 2 inthe skin. Embodiment 32 is the topical skin care composition of any oneof Embodiments 19 to 31, wherein the composition inhibits fatty acidamide hydrolase activity in the skin. Embodiment 33 is the topical skincare composition of any one of Embodiments 19 to 28, wherein thecomposition activates human cannabinoid receptor type 2 and inhibitsfatty acid amide hydrolase activity in the skin.

The compositions and methods for their use can “comprise,” “consistessentially of,” or “consist of” any of the ingredients disclosedthroughout the specification. As used in this specification andclaim(s), the words “comprising” (and any form of comprising, such as“comprise” and “comprises”), “having” (and any form of having, such as“have” and “has”), “including” (and any form of including, such as“includes” and “include”) or “containing” (and any form of containing,such as “contains” and “contain”) are inclusive or open-ended and do notexclude additional, unrecited elements or method steps.

“Consisting essentially of” means that inclusion of additionalingredients in the compositions do not materially affect the beneficialproperties of the compositions as antipruritics and for treating dry,flaky, or cracked skin. For instance, if a composition “consistsessentially of” any one of, any combination of, or 2, 3, or all 4 ofEchinacea purpurea extract, Silybum marianum extract, glycerin, and amixture comprising cetylhydroxyproline palmitamide/steric acid/Brassicacampestris (rapeseed) sterols, said composition excludes any ingredientsthat would materially affect the beneficial properties of thecompositions for treating itchy skin or dry, flaky, or cracked skin. Forinstance, ingredients that can irritate skin or cause drying of the skinor cause an itchy sensation in the skin would be excluded.

It is contemplated that any embodiment discussed in this specificationcan be implemented with respect to any method or composition of theinvention, and vice versa. Furthermore, compositions of the inventioncan be used to achieve methods of the invention.

In one embodiment, compositions of the present invention can bepharmaceutically or cosmetically elegant. “Pharmaceutically elegant”and/or “cosmetically elegant” describes a composition that hasparticular tactile properties which feel pleasant on the skin (e.g.,compositions that are not too watery or greasy, compositions that have asilky texture, compositions that are non-tacky or sticky, etc.).Pharmaceutically or cosmetically elegant can also relate to thecreaminess or lubricity properties of the composition or to the moistureretaining properties of the composition.

“Topical application” means to apply or spread a composition onto thesurface of keratinous tissue. “Topical skin composition” includescompositions suitable for topical application on keratinous tissue. Suchcompositions are typically dermatologically-acceptable in that they donot have undue toxicity, incompatibility, instability, allergicresponse, and the like, when applied to skin. Topical skin carecompositions of the present invention can have a selected viscosity toavoid significant dripping or pooling after application to skin.

“Keratinous tissue” includes keratin-containing layers disposed as theoutermost protective covering of mammals and includes, but is notlimited to, skin, hair and nails.

The term “about” or “approximately” are defined as being close to asunderstood by one of ordinary skill in the art, and in one non-limitingembodiment the terms are defined to be within 10%, preferably within 5%,more preferably within 1%, and most preferably within 0.5%.

The term “substantially” and its variations are defined as being largelybut not necessarily wholly what is specified as understood by one ofordinary skill in the art, and in one non-limiting embodimentsubstantially refers to ranges within 10%, within 5%, within 1%, orwithin 0.5%.

The terms “inhibiting,” “reducing,” “treating,” or any variation ofthese terms, when used in the claims and/or the specification includesany measurable decrease or complete inhibition to achieve a desiredresult.

The term “effective,” as that term is used in the specification and/orclaims, means adequate to accomplish a desired, expected, or intendedresult.

Other objects, features and advantages of the present invention willbecome apparent from the following detailed description. It should beunderstood, however, that the detailed description and the examples,while indicating specific embodiments of the invention, are given by wayof illustration only. Additionally, it is contemplated that changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The itch sensation is typically limited to skin and adjoining mucosaareas. Scratching, however, can lead to skin irritation or erythema,spreading of existing skin conditions (e.g., dry skin such asseborrhoeic dermatitis, atopic eczema, contact dermatitis, or xeroticeczema), and an overall unsightly or visually unpleasing appearance ofthe skin. Dry skin can even lead to fine lines and wrinkles.

The underlying cause of this sensation is due to the activity of nervefibers in the epidermis and upper layers of the dermis. Dry skin, forexample, can activate these nerve fibers, which can induce the feelingof itchy skin, which is oftentimes followed by scratching. Cannabinoidreceptors type 1 (CBr1) and type 2 (CBr2) are located in the epidermis.The CBr2 receptor is a G protein-coupled receptor encoded by the CNR2gene. Some cannabinoid agonists can potentially inhibithistamine-induced itch in skin. In addition, topical agonists ofcannabinoid receptors can have an antipruritic effect in atopic eczemaand uremic pruritus.

Instead of using multiple compositions to treat pruritic skin and dryskin, the inventor discovered a unique combination of ingredients thatcan be incorporated into a topical composition to treat both skinconditions simultaneously. As previously discussed, this combinationincludes a combination of Echinacea purpurea extract, a Silybum marianumextract, glycerin, and/or a mixture comprising cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols.Echinacea purpurea extract was found to bind to human cannabinoidreceptor type 2 (CBr2) in vitro, which activates the CBr2, and Silybummarianum extract was found to inhibit fatty acid amide hydrolase (FAAH)activity. FAAH is known to breakdown cannabinoids, which in-turn canactivate CBr2. The inventor discovered that the combination of theseextracts work in a synergistic fashion to increase and maintain CBr2activity, which can reduce the sensation of itchy or pruitic skin.

These and other non-limiting aspects of the present invention aredescribed in the following subsections.

A. Active Ingredients

Echinacea purpurea is a flowering plant that is native to North America.The extract can be obtained from the whole plant, the root, the flower,the stem, the leaf, the flower/leaf/stem, or the leaf/root. Suchextracts are commercially available from a wide range of sources (see,e.g., International Cosmetic Ingredient Dictionary and Handbook, 12^(th)Edition, 2008 (“CTFA”), Volume 1, pages 918-19, which is incorporated byreference). In particular embodiments, the whole plant extract is used(see page 918 of the CTFA). In some embodiments, the extract is anaqueous extract. The inventor discovered that such extracts can bind tothe CBR2 receptor in human skin.

As for Silybum marianum (Milk thistle), it is a plant native to SouthernEurope and Asia. It is known for producing red to purple flowers, shinypale green leaves with white veins, and fruit. The Silybum marianumextract of the present invention can be a hydroalcohlic (water andalcohol denat) extract that includes silymarin as an active ingredient(silymarin is a mixture of flavanonol derivatives that includessilibine, silicristine, silidianin, isosolibine, and isosilicristine).The fruit portion of Silybum marianum includes silymarin. The Silybummarianum extract can be obtained from the fruit portion of this plant bymascerating the fruit pulp and then subjecting the pulp to ahydroalcoholic solution of water and SD alcohol 39-C (alcohol denat.) toobtain the extract. The extract can then filtered and packaged forstorage or be added to a composition of the present invention. Inaddition to this extraction process, Silybum marianum extract can bepurchased from Provital S.A (SPAIN) under the trade names PRONALENSILYMARIN HSC or PRONALEN SILYMARIN SPE. In some embodiments, theextract is an aqueous extract. This extract can be used to treat theinflammatory response in skin caused, for example, by dry skin.

Turning to glycerin, it is a polyhydric alcohol that has the followingchemical structure:

It too is commercially available from a wide range of sources (see,e.g., International Cosmetic Ingredient Dictionary and Handbook, 12^(th)Edition, 2008 (“CTFA”), Volume 1, pages 1050-61, which is incorporatedby reference). Glycerin is a known moisturizer for skin.

As for a mixture comprising cetylhydroxyproline palmitamide/stericacid/Brassica campestris (rapeseed) sterols, such a mixture is availablefrom Symrise (Germany) under the trade name SymRepair®. The SymRepair®product is a combination of Hexyldecanol, Bisabolol, Stearic Acid,Cetylhydroxyproline Palmitamide, and Brassica campestris (Rapeseed)Sterols.

Further, and as noted above, the compositions of the present inventioncan also include rosmarinic acid-α-D-glucoside. This compound is anester formed between rosmarinic acid and glucose. It has the followingchemical structure:

It is commercially available from LibraGen (Toulouse, France) under thetrade name Rosmarinyl™ Glucoside. This ingredient can be used to treatthe inflammatory response in skin caused, for example, by dry skin.

In addition to the commercially availability of the extracts identifiedabove, said extracts can be produced by obtaining the correspondingplant or portion thereof to produce the extract by extraction methodswhich are known to those of ordinary skill in the art. For instance, aperson of ordinary skill in the art would be able to isolate any one ofthe extracts identified above from the whole plant or parts of thecorresponding plant by using any suitable method known in the art. Inone non-limiting example, the plant (or any part of the plant) can bedisrupted by mechanical means which results in a puree. The puree isthen processed to be substantially free of impurities or undesiredsolids. The puree can then be poured into a shallow vessel and quicklyexposed to low temperature, i.e., flash frozen, for example at −20° C.or lower, preferably under a vacuum for removal of water content(lyophilization). The resultant extract can then be used in thecompositions of the present invention.

In other aspects, aqueous, alcoholic, aqueous-alcoholic, or oil basedextraction techniques, or combinations thereof, can be used on the wholeplant or any part thereof of to produce an extract. In such a process,the desired part of the plant or the whole plant is crushed up (e.g.,blender) and then subjected to a desired solvent (e.g., water, alcohol,water/alcohol, or oil based solvents) to obtain the desired extract. Theextract can then be stored in liquid form, lyophilized, or subject tofurther processing techniques (e.g., heating, cooling, etc.). Extractionprocesses are well-known to those having ordinary skill in the extractfield (e.g., maceration, infusion, percolation, digestion, decoction,hot continuous extraction, aqueous-alcoholic extract, counter currentextract, microwave assisted extraction, ultrasound extraction,supercritical fluid extracts, phytonic extract (e.g., withhydro-flouro-carbon solvents), etc.

B. Compositions of the Present Invention

It is contemplated that the compositions of the present invention caninclude any of the actives or any combination thereof describedthroughout this specification. In particular aspects, the actives can becombined (e.g., an Echinacea purpurea extract, a Silybum marianumextract, glycerin, and a mixture comprising cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols). Thecompositions can include any number of combinations of additionalingredients described throughout this specification. The concentrationsof the any ingredient within the compositions can vary. In non-limitingembodiments, for example, the compositions can comprise, consistingessentially of, or consist of, in their final form, for example, atleast about 0.0001%, 0.0002%, 0.0003%, 0.0004%, 0.0005%, 0.0006%,0.0007%, 0.0008%, 0.0009%, 0.0010%, 0.0011%, 0.0012%, 0.0013%, 0.0014%,0.0015%, 0.0016%, 0.0017%, 0.0018%, 0.0019%, 0.0020%, 0.0021%, 0.0022%,0.0023%, 0.0024%, 0.0025%, 0.0026%, 0.0027%, 0.0028%, 0.0029%, 0.0030%,0.0031%, 0.0032%, 0.0033%, 0.0034%, 0.0035%, 0.0036%, 0.0037%, 0.0038%,0.0039%, 0.0040%, 0.0041%, 0.0042%, 0.0043%, 0.0044%, 0.0045%, 0.0046%,0.0047%, 0.0048%, 0.0049%, 0.0050%, 0.0051%, 0.0052%, 0.0053%, 0.0054%,0.0055%, 0.0056%, 0.0057%, 0.0058%, 0.0059%, 0.0060%, 0.0061%, 0.0062%,0.0063%, 0.0064%, 0.0065%, 0.0066%, 0.0067%, 0.0068%, 0.0069%, 0.0070%,0.0071%, 0.0072%, 0.0073%, 0.0074%, 0.0075%, 0.0076%, 0.0077%, 0.0078%,0.0079%, 0.0080%, 0.0081%, 0.0082%, 0.0083%, 0.0084%, 0.0085%, 0.0086%,0.0087%, 0.0088%, 0.0089%, 0.0090%, 0.0091%, 0.0092%, 0.0093%, 0.0094%,0.0095%, 0.0096%, 0.0097%, 0.0098%, 0.0099%, 0.0100%, 0.0200%, 0.0250%,0.0275%, 0.0300%, 0.0325%, 0.0350%, 0.0375%, 0.0400%, 0.0425%, 0.0450%,0.0475%, 0.0500%, 0.0525%, 0.0550%, 0.0575%, 0.0600%, 0.0625%, 0.0650%,0.0675%, 0.0700%, 0.0725%, 0.0750%, 0.0775%, 0.0800%, 0.0825%, 0.0850%,0.0875%, 0.0900%, 0.0925%, 0.0950%, 0.0975%, 0.1000%, 0.1250%, 0.1500%,0.1750%, 0.2000%, 0.2250%, 0.2500%, 0.2750%, 0.3000%, 0.3250%, 0.3500%,0.3750%, 0.4000%, 0.4250%, 0.4500%, 0.4750%, 0.5000%, 0.5250%, 0.0550%,0.5750%, 0.6000%, 0.6250%, 0.6500%, 0.6750%, 0.7000%, 0.7250%, 0.7500%,0.7750%, 0.8000%, 0.8250%, 0.8500%, 0.8750%, 0.9000%, 0.9250%, 0.9500%,0.9750%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%,2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9%, 3.0%, 3.1%,3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4.0%, 4.1%, 4.2%, 4.3%,4.4%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9%, 5.0%, 5.1%, 5.2%, 5.3%, 5.4%, 5.5%,5.6%, 5.7%, 5.8%, 5.9%, 6.0%, 6.1%, 6.2%, 6.3%, 6.4%, 6.5%, 6.6%, 6.7%,6.8%, 6.9%, 7.0%, 7.1%, 7.2%, 7.3%, 7.4%, 7.5%, 7.6%, 7.7%, 7.8%, 7.9%,8.0%, 8.1%, 8.2%, 8.3%, 8.4%, 8.5%, 8.6%, 8.7%, 8.8%, 8.9%, 9.0%, 9.1%,9.2%, 9.3%, 9.4%, 9.5%, 9.6%, 9.7%, 9.8%, 9.9%, 10%, 11%, 12%, 13%, 14%,15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%,29%, 30%, 35%, 40%, 45%, 50%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or99% or any range derivable therein, of at least one of the ingredientsthat are mentioned throughout the specification and claims. Innon-limiting aspects, the percentage can be calculated by weight orvolume of the total composition. A person of ordinary skill in the artwould understand that the concentrations can vary depending on theaddition, substitution, and/or subtraction of ingredients in a givencomposition.

The disclosed compositions of the present invention may also includevarious antioxidants to retard oxidation of one or more components.Additionally, the prevention of the action of microorganisms can bebrought about by preservatives such as various antibacterial andantifungal agents, including but not limited to parabens (e.g.,methylparabens, propylparabens), chlorobutanol, phenol, sorbic acid,thimerosal or combinations thereof. In some embodiments, thecompositions do not contain parabens.

C. Vehicles

The compositions of the present invention can be incorporated into alltypes of vehicles. Non-limiting examples of suitable vehicles includeemulsions (e.g., water-in-oil, water-in-oil-in-water, oil-in-water,silicone-in-water, water-in-silicone, oil-in-water-in-oil,oil-in-water-in-silicone emulsions), creams, lotions, solutions (bothaqueous and hydro-alcoholic), anhydrous bases (such as lipsticks andpowders), gels, and ointments or by other method or any combination ofthe forgoing as would be known to one of ordinary skill in the art(Remington's, 1990). Variations and other appropriate vehicles will beapparent to the skilled artisan and are appropriate for use in thepresent invention. In certain aspects, it is important that theconcentrations and combinations of the compounds, ingredients, andagents be selected in such a way that the combinations are chemicallycompatible and do not form complexes which precipitate from the finishedproduct.

It is also contemplated that ingredients identified throughout thisspecification, including but not limited to an Echinacea purpureaextract, a Silybum marianum extract, glycerin, and a mixture comprisingcetylhydroxyproline palmitamide/steric acid/Brassica campestris(rapeseed) sterols, or any combinations thereof, can be individually orcombinatorially encapsulated for delivery to a target area such as skin.Non-limiting examples of encapsulation techniques include the use ofliposomes, vesicles, and/or nanoparticles (e.g., biodegradable andnon-biodegradable colloidal particles comprising polymeric materials inwhich the ingredient is trapped, encapsulated, and/or absorbed—examplesinclude nanospheres and nanocapsules) that can be used as deliveryvehicles to deliver the ingredient to skin (see, e.g., U.S. Pat. Nos.6,387,398; 6,203,802; 5,411,744; Kreuter 1998).

D. Cosmetic Products and Articles of Manufacture

The composition of the present invention can also be used in manycosmetic products including, but not limited to, sunscreen products,sunless skin tanning products, hair products, finger nail products,moisturizing creams, skin benefit creams and lotions, softeners, daylotions, gels, ointments, foundations, night creams, lipsticks,cleansers, toners, masks, or other known cosmetic products orapplications. Additionally, the cosmetic products can be formulated asleave-on or rinse-off products. In certain aspects, the compositions ofthe present invention are stand-alone products.

E. Additional Ingredients

In addition to the Echinacea purpurea extract, Silybum marianum extract,glycerin, and a mixture comprising cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols,ingredients disclosed throughout this specification, compositions of thepresent invention can include additional ingredients such as cosmeticingredients and pharmaceutical active ingredients. Non-limiting examplesof these additional ingredients are described in the followingsubsections.

1. Cosmetic Ingredients

The CTFA International Cosmetic Ingredient Dictionary and Handbook (2004and 2008) describes a wide variety of non-limiting cosmetic ingredientsthat can be used in the context of the present invention. Examples ofthese ingredient classes include: fragrances (artificial and natural),dyes and color ingredients (e.g., Blue 1, Blue 1 Lake, Red 40, titaniumdioxide, D&C blue no. 4, D&C green no. 5, D&C orange no. 4, D&C red no.17, D&C red no. 33, D&C violet no. 2, D&C yellow no. 10, and D&C yellowno. 11), adsorbents, lubricants, solvents, moisturizers (including,e.g., emollients, humectants, film formers, occlusive agents, and agentsthat affect the natural moisturization mechanisms of the skin),water-repellants, UV absorbers (physical and chemical absorbers such asparaaminobenzoic acid (“PABA”) and corresponding PABA derivatives,titanium dioxide, zinc oxide, etc.), essential oils, vitamins (e.g. A,B, C, D, E, and K), trace metals (e.g. zinc, calcium and selenium),anti-irritants (e.g. steroids and non-steroidal anti-inflammatories),botanical extracts (e.g. Aloe vera, chamomile, cucumber extract, Ginkgobiloba, Ginseng, and rosemary), anti-microbial agents, antioxidants(e.g., BHT and tocopherol), chelating agents (e.g., disodium EDTA andtetrasodium EDTA), preservatives (e.g., methylparaben andpropylparaben), pH adjusters (e.g., sodium hydroxide and citric acid),absorbents (e.g., aluminum starch octenylsuccinate, kaolin, corn starch,oat starch, cyclodextrin, talc, and zeolite), skin bleaching andlightening agents (e.g., hydroquinone and niacinamide lactate),humectants (e.g., sorbitol, urea, and manitol), exfoliants,waterproofing agents (e.g., magnesium/aluminum hydroxide stearate), skinconditioning agents (e.g., aloe extracts, allantoin, bisabolol,ceramides, dimethicone, hyaluronic acid, and dipotassium glycyrrhizate).Non-limiting examples of some of these ingredients are provided in thefollowing subsections.

a. UV Absorption Agents

UV absorption agents that can be used in combination with thecompositions of the present invention include chemical and physicalsunblocks. Non-limiting examples of chemical sunblocks that can be usedinclude para-aminobenzoic acid (PABA), PABA esters (glyceryl PABA,amyldimethyl PABA and octyldimethyl PABA), butyl PABA, ethyl PABA, ethyldihydroxypropyl PABA, benzophenones (oxybenzone, sulisobenzone,benzophenone, and benzophenone-1 through 12), cinnamates (octylmethoxycinnamate, isoamyl p-methoxycinnamate, octylmethoxy cinnamate,cinoxate, diisopropyl methyl cinnamate, DEA-methoxycinnamate, ethyldiisopropylcinnamate, glyceryl octanoate dimethoxycinnamate and ethylmethoxycinnamate), cinnamate esters, salicylates (homomethyl salicylate,benzyl salicylate, glycol salicylate, isopropylbenzyl salicylate, etc.),anthranilates, ethyl urocanate, homosalate, octisalate, dibenzoylmethanederivatives (e.g., avobenzone), octocrylene, octyl triazone, digalloytrioleate, glyceryl aminobenzoate, lawsone with dihydroxyacetone,ethylhexyl triazone, dioctyl butamido triazone, benzylidene malonatepolysiloxane, terephthalylidene dicamphor sulfonic acid, disodium phenyldibenzimidazole tetrasulfonate, diethylamino hydroxybenzoyl hexylbenzoate, bis diethylamino hydroxybenzoyl benzoate, bisbenzoxazoylphenyl ethylhexylimino triazine, drometrizole trisiloxane,methylene bis-benzotriazolyl tetramethylbutyiphenol, andbis-ethylhexyloxyphenol methoxyphenyltriazine,4-methylbenzylidenecamphor, and isopentyl 4-methoxycinnamate.Non-limiting examples of physical sunblocks include, kaolin, talc,petrolatum and metal oxides (e.g., titanium dioxide and zinc oxide).

b. Moisturizing Agents

Non-limiting examples of moisturizing agents that can be used with thecompositions of the present invention include amino acids, chondroitinsulfate, diglycerin, erythritol, fructose, glucose, glycerin, glycerolpolymers, glycol, 1,2,6-hexanetriol, honey, hyaluronic acid,hydrogenated honey, hydrogenated starch hydrolysate, inositol, lactitol,maltitol, maltose, mannitol, natural moisturizing factor, PEG-15butanediol, polyglyceryl sorbitol, salts of pyrollidone carboxylic acid,potassium PCA, propylene glycol, sodium glucuronate, sodium PCA,sorbitol, sucrose, trehalose, urea, and xylitol.

Other examples include acetylated lanolin, acetylated lanolin alcohol,alanine, algae extract, Aloe barbadensis, Aloe-barbadensis extract, Aloebarbadensis gel, Althea officinalis extract, apricot (Prunus armeniaca)kernel oil, arginine, arginine aspartate, Arnica montana extract,aspartic acid, avocado (Persea gratissima) oil, barrier sphingolipids,butyl alcohol, beeswax, behenyl alcohol, beta-sitosterol, birch (Betulaalba) bark extract, borage (Borago officinalis) extract, butcherbroom(Ruscus aculeatus) extract, butylene glycol, calendula officinalisextract, Calendula officinalis oil, candelilla (Euphorbia cerifera) wax,canola oil, caprylic/capric triglyceride, cardamon (Elettariacardamomum) oil, carnauba (Copernicia cerifera) wax, carrot (Daucuscarota sativa) oil, castor (Ricinus communis) oil, ceramides, ceresin,ceteareth-5, ceteareth-12, ceteareth-20, cetearyl octanoate, ceteth-20,ceteth-24, cetyl acetate, cetyl octanoate, cetyl palmitate, chamomile(Anthemis nobilis) oil, cholesterol, cholesterol esters, cholesterylhydroxystearate, citric acid, clary (Salvia sclarea) oil, cocoa(Theobroma cacao) butter, coco-caprylate/caprate, coconut (Cocosnucifera) oil, collagen, collagen amino acids, corn (Zea mays) oil,fatty acids, decyl oleate, dimethicone copolyol, dimethiconol, dioctyladipate, dioctyl succinate, dipentaerythrityl hexacaprylate/hexacaprate,DNA, erythritol, ethoxydiglycol, ethyl linoleate, Eucalyptus globulusoil, evening primrose (Oenothera biennis) oil, fatty acids, Geraniummaculatum oil, glucosamine, glucose glutamate, glutamic acid,glycereth-26, glycerin, glycerol, glyceryl distearate, glycerylhydroxystearate, glyceryl laurate, glyceryl linoleate, glycerylmyristate, glyceryl oleate, glyceryl stearate, glyceryl stearate SE,glycine, glycol stearate, glycol stearate SE, glycosaminoglycans, grape(Vitis vinifera) seed oil, hazel (Corylus americana) nut oil, hazel(Corylus avellana) nut oil, hexylene glycol, hyaluronic acid, hybridsafflower (Carthamus tinctorius) oil, hydrogenated castor oil,hydrogenated coco-glycerides, hydrogenated coconut oil, hydrogenatedlanolin, hydrogenated lecithin, hydrogenated palm glyceride,hydrogenated palm kernel oil, hydrogenated soybean oil, hydrogenatedtallow glyceride, hydrogenated vegetable oil, hydrolyzed collagen,hydrolyzed elastin, hydrolyzed glycosaminoglycans, hydrolyzed keratin,hydrolyzed soy protein, hydroxylated lanolin, hydroxyproline, isocetylstearate, isocetyl stearoyl stearate, isodecyl oleate, isopropylisostearate, isopropyl lanolate, isopropyl myristate, isopropylpalmitate, isopropyl stearate, isostearamide DEA, isostearic acid,isostearyl lactate, isostearyl neopentanoate, jasmine (Jasminumofficinale) oil, jojoba (Buxus chinensis) oil, kelp, kukui (Aleuritesmoluccana) nut oil, lactamide MEA, laneth-16, laneth-10 acetate,lanolin, lanolin acid, lanolin alcohol, lanolin oil, lanolin wax,lavender (Lavandula angustifolia) oil, lecithin, lemon (Citrus medicalimonum) oil, linoleic acid, linolenic acid, Macadamia ternifolia nutoil, maltitol, Matricaria (Chamomilla recutita) oil, methyl glucosesesquistearate, methylsilanol PCA, mineral oil, mink oil, Mortierellaoil, myristyl lactate, myristyl myristate, myristyl propionate,neopentyl glycol dicaprylate/dicaprate, octyldodecanol, octyldodecylmyristate, octyldodecyl stearoyl stearate, octyl hydroxystearate, octylpalmitate, octyl salicylate, octyl stearate, oleic acid, olive (Oleaeuropaea) oil, orange (Citrus aurantium dulcis) oil, palm (Elaeisguineensis) oil, palmitic acid, pantethine, panthenol, panthenyl ethylether, paraffin, PCA, peach (Prunus persica) kernel oil, peanut (Arachishypogaea) oil, PEG-8 C12-18 ester, PEG-15 cocamine, PEG-150 distearate,PEG-60 glyceryl isostearate, PEG-5 glyceryl stearate, PEG-30 glycerylstearate, PEG-7 hydrogenated castor oil, PEG-40 hydrogenated castor oil,PEG-60 hydrogenated castor oil, PEG-20 methyl glucose sesquistearate,PEG40 sorbitan peroleate, PEG-5 soy sterol, PEG-10 soy sterol, PEG-2stearate, PEG-8 stearate, PEG-20 stearate, PEG-32 stearate, PEG40stearate, PEG-50 stearate, PEG-100 stearate, PEG-150 stearate,pentadecalactone, peppermint (Mentha piperita) oil, petrolatum,phospholipids, polyamino sugar condensate, polyglyceryl-3 diisostearate,polyquaternium-24, polysorbate 20, polysorbate 40, polysorbate 60,polysorbate 80, polysorbate 85, potassium myristate, potassiumpalmitate, propylene glycol, propylene glycol dicaprylate/dicaprate,propylene glycol dioctanoate, propylene glycol dipelargonate, propyleneglycol laurate, propylene glycol stearate, propylene glycol stearate SE,PVP, pyridoxine dipalmitate, retinol, retinyl palmitate, rice (Oryzasativa) bran oil, RNA, rosemary (Rosmarinus officinalis) oil, rose oil,safflower (Carthamus tinctorius) oil, sage (Salvia officinalis) oil,sandalwood (Santalum album) oil, serine, serum protein, sesame (Sesamumindicum) oil, shea butter (Butyrospermum parkii), silk powder, sodiumchondroitin sulfate, sodium hyaluronate, sodium lactate, sodiumpalmitate, sodium PCA, sodium polyglutamate, soluble collagen, sorbitanlaurate, sorbitan oleate, sorbitan palmitate, sorbitan sesquioleate,sorbitan stearate, sorbitol, soybean (Glycine soja) oil, sphingolipids,squalane, squalene, stearamide MEA-stearate, stearic acid, stearoxydimethicone, stearoxytrimethylsilane, stearyl alcohol, stearylglycyrrhetinate, stearyl heptanoate, stearyl stearate, sunflower(Helianthus annuus) seed oil, sweet almond (Prunus amygdalus dulcis)oil, synthetic beeswax, tocopherol, tocopheryl acetate, tocopheryllinoleate, tribehenin, tridecyl neopentanoate, tridecyl stearate,triethanolamine, tristearin, urea, vegetable oil, water, waxes, wheat(Triticum vulgare) germ oil, and ylang ylang (Cananga odorata) oil.

c. Antioxidants

Non-limiting examples of antioxidants that can be used with thecompositions of the present invention include acetyl cysteine, ascorbicacid polypeptide, ascorbyl dipalmitate, ascorbyl methylsilanolpectinate, ascorbyl palmitate, ascorbyl stearate, BHA, BHT, t-butylhydroquinone, cysteine, cysteine HCl, diamylhydroquinone,di-t-butylhydroquinone, dicetyl thiodipropionate, dioleyl tocopherylmethylsilanol, disodium ascorbyl sulfate, distearyl thiodipropionate,ditridecyl thiodipropionate, dodecyl gallate, erythorbic acid, esters ofascorbic acid, ethyl ferulate, ferulic acid, gallic acid esters,hydroquinone, isooctyl thioglycolate, kojic acid, magnesium ascorbate,magnesium ascorbyl phosphate, methylsilanol ascorbate, natural botanicalanti-oxidants such as green tea or grape seed extracts,nordihydroguaiaretic acid, octyl gallate, phenylthioglycolic acid,potassium ascorbyl tocopheryl phosphate, potassium sulfite, propylgallate, quinones, rosmarinic acid, sodium ascorbate, sodium bisulfite,sodium erythorbate, sodium metabisulfite, sodium sulfite, superoxidedismutase, sodium thioglycolate, sorbityl furfural, thiodiglycol,thiodiglycolamide, thiodiglycolic acid, thioglycolic acid, thiolacticacid, thiosalicylic acid, tocophereth-5, tocophereth-10, tocophereth-12,tocophereth-18, tocophereth-50, tocopherol, tocophersolan, tocopherylacetate, tocopheryl linoleate, tocopheryl nicotinate, tocopherylsuccinate, and tris(nonylphenyl)phosphite.

d. Structuring Agents

In other non-limiting aspects, the compositions of the present inventioncan include a structuring agent. Structuring agent, in certain aspects,assist in providing rheological characteristics to the composition tocontribute to the composition's stability. In other aspects, structuringagents can also function as an emulsifier or surfactant. Non-limitingexamples of structuring agents include stearic acid, palmitic acid,stearyl alcohol, cetyl alcohol, behenyl alcohol, stearic acid, palmiticacid, the polyethylene glycol ether of stearyl alcohol having an averageof about 1 to about 21 ethylene oxide units, the polyethylene glycolether of cetyl alcohol having an average of about 1 to about 5 ethyleneoxide units, and mixtures thereof.

e. Emulsifiers

In certain aspects of the present invention, the compositions do notinclude an emulsifier. In other aspects, however, the compositions caninclude one or more emulsifiers. Emulsifiers can reduce the interfacialtension between phases and improve the formulation and stability of anemulsion. The emulsifiers can be nonionic, cationic, anionic, andzwitterionic emulsifiers (See McCutcheon's 1986; U.S. Pat. Nos.5,011,681; 4,421,769; 3,755,560). Non-limiting examples include estersof glycerin, esters of propylene glycol, fatty acid esters ofpolyethylene glycol, fatty acid esters of polypropylene glycol, estersof sorbitol, esters of sorbitan anhydrides, carboxylic acid copolymers,esters and ethers of glucose, ethoxylated ethers, ethoxylated alcohols,alkyl phosphates, polyoxyethylene fatty ether phosphates, fatty acidamides, acyl lactylates, soaps, TEA stearate, DEA oleth-3 phosphate,polyethylene glycol 20 sorbitan monolaurate (polysorbate 20),polyethylene glycol 5 soya sterol, steareth-2, steareth-20, steareth-21,ceteareth-20, PPG-2 methyl glucose ether distearate, ceteth-10,polysorbate 80, cetyl phosphate, potassium cetyl phosphate,diethanolamine cetyl phosphate, polysorbate 60, glyceryl stearate,PEG-100 stearate, and mixtures thereof.

f. Silicone Containing Compounds

In non-limiting aspects, silicone containing compounds include anymember of a family of polymeric products whose molecular backbone ismade up of alternating silicon and oxygen atoms with side groupsattached to the silicon atoms. By varying the —Si—O— chain lengths, sidegroups, and crosslinking, silicones can be synthesized into a widevariety of materials. They can vary in consistency from liquid to gel tosolids.

The silicone containing compounds that can be used in the context of thepresent invention include those described in this specification or thoseknown to a person of ordinary skill in the art. Non-limiting examplesinclude silicone oils (e.g., volatile and non-volatile oils), gels, andsolids. In certain aspects, the silicon containing compounds includes asilicone oils such as a polyorganosiloxane. Non-limiting examples ofpolyorganosiloxanes include dimethicone, cyclomethicone,polysilicone-11, phenyl trimethicone, trimethylsilylamodimethicone,stearoxytrimethylsilane, or mixtures of these and other organosiloxanematerials in any given ratio in order to achieve the desired consistencyand application characteristics depending upon the intended application(e.g., to a particular area such as the skin, hair, or eyes). A“volatile silicone oil” includes a silicone oil have a low heat ofvaporization, i.e. normally less than about 50 cal per gram of siliconeoil. Non-limiting examples of volatile silicone oils include:cyclomethicones such as Dow Corning 344 Fluid, Dow Corning 345 Fluid,Dow Corning 244 Fluid, and Dow Corning 245 Fluid, Volatile Silicon 7207(Union Carbide Corp., Danbury, Conn.); low viscosity dimethicones, i.e.dimethicones having a viscosity of about 50 cst or less (e.g.,dimethicones such as Dow Corning 200-0.5 cst Fluid). The Dow CorningFluids are available from Dow Corning Corporation, Midland, Mich.Cyclomethicone and dimethicone are described in the Third Edition of theCTFA Cosmetic Ingredient Dictionary (incorporated by reference) ascyclic dimethyl polysiloxane compounds and a mixture of fully methylatedlinear siloxane polymers end-blocked with trimethylsiloxy units,respectively. Other non-limiting volatile silicone oils that can be usedin the context of the present invention include those available fromGeneral Electric Co., Silicone Products Div., Waterford, N.Y. and SWSSilicones Div. of Stauffer Chemical Co., Adrian, Mich.

g. Essential Oils

Essential oils include oils derived from herbs, flowers, trees, andother plants. Such oils are typically present as tiny droplets betweenthe plant's cells, and can be extracted by several methods known tothose of skill in the art (e.g., steam distilled, enfleurage (i.e.,extraction by using fat), maceration, solvent extraction, or mechanicalpressing). When these types of oils are exposed to air they tend toevaporate (i.e., a volatile oil). As a result, many essential oils arecolorless, but with age they can oxidize and become darker. Essentialoils are insoluble in water and are soluble in alcohol, ether, fixedoils (vegetal), and other organic solvents. Typical physicalcharacteristics found in essential oils include boiling points that varyfrom about 160° to 240° C. and densities ranging from about 0.759 toabout 1.096.

Essential oils typically are named by the plant from which the oil isfound. For example, rose oil or peppermint oil are derived from rose orpeppermint plants, respectively. Non-limiting examples of essential oilsthat can be used in the context of the present invention include sesameoil, macadamia nut oil, tea tree oil, evening primrose oil, Spanish sageoil, Spanish rosemary oil, coriander oil, thyme oil, pimento berriesoil, rose oil, anise oil, balsam oil, bergamot oil, rosewood oil, cedaroil, chamomile oil, sage oil, clary sage oil, clove oil, cypress oil,eucalyptus oil, fennel oil, sea fennel oil, frankincense oil, geraniumoil, ginger oil, grapefruit oil, jasmine oil, juniper oil, lavender oil,lemon oil, lemongrass oil, lime oil, mandarin oil, marjoram oil, myrrhoil, neroli oil, orange oil, patchouli oil, pepper oil, black pepperoil, petitgrain oil, pine oil, rose otto oil, rosemary oil, sandalwoodoil, spearmint oil, spikenard oil, vetiver oil, wintergreen oil, orylang ylang. Other essential oils known to those of skill in the art arealso contemplated as being useful within the context of the presentinvention.

h. Thickening Agents

Thickening agents, including thickener or gelling agents, includesubstances which that can increase the viscosity of a composition.Thickeners includes those that can increase the viscosity of acomposition without substantially modifying the efficacy of the activeingredient within the composition. Thickeners can also increase thestability of the compositions of the present invention. In certainaspects of the present invention, thickeners include hydrogenatedpolyisobutene or trihydroxystearin, or a mixture of both.

Non-limiting examples of additional thickening agents that can be usedin the context of the present invention include carboxylic acidpolymers, crosslinked polyacrylate polymers, polyacrylamide polymers,polysaccharides, and gums. Examples of carboxylic acid polymers includecrosslinked compounds containing one or more monomers derived fromacrylic acid, substituted acrylic acids, and salts and esters of theseacrylic acids and the substituted acrylic acids, wherein thecrosslinking agent contains two or more carbon-carbon double bonds andis derived from a polyhydric alcohol (see U.S. Pat. Nos. 5,087,445;4,509,949; 2,798,053; CTFA International Cosmetic Ingredient Dictionary,Fourth edition, 1991, pp. 12 and 80). Examples of commercially availablecarboxylic acid polymers include carbomers, which are homopolymers ofacrylic acid crosslinked with allyl ethers of sucrose or pentaerytritol(e.g., Carbopol™ 900 series from B. F. Goodrich).

Non-limiting examples of crosslinked polyacrylate polymers includecationic and nonionic polymers. Examples are described in U.S. Pat. Nos.5,100,660; 4,849,484; 4,835,206; 4,628,078; 4,599,379.

Non-limiting examples of polyacrylamide polymers (including nonionicpolyacrylamide polymers including substituted branched or unbranchedpolymers) include polyacrylamide, isoparaffin and laureth-7, multi-blockcopolymers of acrylamides and substituted acrylamides with acrylic acidsand substituted acrylic acids.

Non-limiting examples of polysaccharides include cellulose,carboxymethyl hydroxyethylcellulose, cellulose acetate propionatecarboxylate, hydroxyethylcellulose, hydroxyethyl ethylcellulose,hydroxypropylcellulose, hydroxypropyl methylcellulose, methylhydroxyethylcellulose, microcrystalline cellulose, sodium cellulosesulfate, and mixtures thereof Another example is an alkyl substitutedcellulose where the hydroxy groups of the cellulose polymer ishydroxyalkylated (preferably hydroxy ethylated or hydroxypropylated) toform a hydroxyalkylated cellulose which is then further modified with aC₁₀-C₃₀ straight chain or branched chain alkyl group through an etherlinkage. Typically these polymers are ethers of C₁₀-C₃₀ straight orbranched chain alcohols with hydroxyalkylcelluloses. Other usefulpolysaccharides include scleroglucans comprising a linear chain of (1-3)linked glucose units with a (1-6) linked glucose every three unit.

Non-limiting examples of gums that can be used with the presentinvention include acacia, agar, algin, alginic acid, ammonium alginate,amylopectin, calcium alginate, calcium carrageenan, carnitine,carrageenan, dextrin, gelatin, gellan gum, guar gum, guarhydroxypropyltrimonium chloride, hectorite, hyaluroinic acid, hydratedsilica, hydroxypropyl chitosan, hydroxypropyl guar, karaya gum, kelp,locust bean gum, natto gum, potassium alginate, potassium carrageenan,propylene glycol alginate, sclerotium gum, sodium carboyxmethyl dextran,sodium carrageenan, tragacanth gum, xanthan gum, and mixtures thereof.

i. Preservatives

Non-limiting examples of preservatives that can be used in the contextof the present invention include quaternary ammonium preservatives suchas polyquaternium-1 and benzalkonium halides (e.g., benzalkoniumchloride (“BAC”) and benzalkonium bromide), parabens (e.g.,methylparabens and propylparabens), phenoxyethanol, benzyl alcohol,chlorobutanol, phenol, sorbic acid, thimerosal or combinations thereof.

2. Pharmaceutical Ingredients

Pharmaceutical active agents are also contemplated as being useful withthe compositions of the present invention. Non-limiting examples ofpharmaceutical active agents include anti-acne agents, agents used totreat rosacea, analgesics, anesthetics, anorectals, antihistamines,anti-inflammatory agents including non-steroidal anti-inflammatorydrugs, antibiotics, antifungals, antivirals, antimicrobials, anti-canceractives, scabicides, pediculicides, antineoplastics, antiperspirants,antipruritics, antipsoriatic agents, anti seborrheic agents,biologically active proteins and peptides, burn treatment agents,cauterizing agents, depigmenting agents, depilatories, diaper rashtreatment agents, enzymes, hair growth stimulants, hair growthretardants including DFMO and its salts and analogs, hemostatics,kerotolytics, canker sore treatment agents, cold sore treatment agents,dental and periodontal treatment agents, photosensitizing actives, skinprotectant/barrier agents, steroids including hormones andcorticosteroids, sunburn treatment agents, sunscreens, transdermalactives, nasal actives, vaginal actives, wart treatment agents, woundtreatment agents, wound healing agents, etc.

F. Kits

Kits are also contemplated as being used in certain aspects of thepresent invention. For instance, compositions of the present inventioncan be included in a kit. A kit can include a container. Containers caninclude a bottle, a metal tube, a laminate tube, a plastic tube, adispenser, a pressurized container, a barrier container, a package, acompartment, a lipstick container, a compact container, cosmetic pansthat can hold cosmetic compositions, or other types of containers suchas injection or blow-molded plastic containers into which thedispersions or compositions or desired bottles, dispensers, or packagesare retained. The kit and/or container can include indicia on itssurface. The indicia, for example, can be a word, a phrase, anabbreviation, a picture, or a symbol.

The containers can dispense a pre-determined amount of the composition.In other embodiments, the container can be squeezed (e.g., metal,laminate, or plastic tube) to dispense a desired amount of thecomposition. The composition can be dispensed as a spray, an aerosol, aliquid, a fluid, or a semi-solid. The containers can have spray, pump,or squeeze mechanisms. A kit can also include instructions for employingthe kit components as well the use of any other compositions included inthe container. Instructions can include an explanation of how to apply,use, and maintain the compositions.

EXAMPLES

The following examples are included to demonstrate certain non-limitingaspects of the invention. It should be appreciated by those of skill inthe art that the techniques disclosed in the examples which followrepresent techniques discovered by the inventor to function well in thepractice of the invention. However, those of skill in the art should, inlight of the present disclosure, appreciate that many changes can bemade in the specific embodiments which are disclosed and still obtain alike or similar result without departing from the spirit and scope ofthe invention.

Example 1 Non-Limiting Examples of Compositions

Echinacea purpurea extract (Naturex (France)) was found to bind to humancannabinoid receptor type 2 (CBr2) in vitro. It was also shown to be anantioxidant using the Trolox equivalent antioxidant capacity (TEAC) testand an enzyme inhibitor using a lipoxygenase (LO) assay. Such datasuggests that this extract can inhibit the sensory nerve fibers thatmodulate itchiness in skin (data not shown). Silybum marianum extract(Provital S.A (SPAIN)) was found to inhibit fatty acid amide hydrolase(FAAH) activity. FAAH is known to breakdown cannabinoids, which in-turncan activate CBr2. Silybum marianum extract was also found to inhibitCOX-1 and COX-2 (LO assay), inhibit keratinocyte inflammatory cytokines,including TNFalpha, CGRP, IL-1, IL-6, and IL-8, and be an antioxidant(ORAC test, TEAC test). The inventor discovered that the combination ofthese extracts work in a synergistic fashion to increase and maintainCBr2 activity, which can reduce the sensation of itchy or pruitic skin.

Glycerin is a known moisturizer. The mixture comprisingcetylhydroxyproline palmitamide/steric acid/Brassica campestris(rapeseed) sterols sold by Symrise under the trade name SymRepair® isalso known to have skin moisturization properties.

The inventors believe that by combining each of the above ingredientsinto a single composition, the overall effect would be to treat itchyskin while also treating dry, cracked, or flaky skin. A person havingordinary skill in the art could also use the testing vehicle in Tables 1and 2 to determine the effects of this combination of ingredients onitchy skin or dry, flaky, or cracked skin.

TABLE 1* Ingredient % Concentration (by weight) Phase A Water q.s. to100 Xanthum gum 0.1 M-paraben 0.15 P-paraben 0.1 Citric acid 0.01 PhaseB Cetyl alcohol 4.0 Glyceryl stearate + PEG 100 4.0 Octyl palmitate 4.0Dimethicone 1.0 Tocopheryl acetate 0.2 Phase C Active Ingredients** 5.0*Sprinkle Xanthum gum in water and mix for 10 min. Subsequently, add allingredients in phase A and heat to 70-75° C. Add all items in phase B toseparate beaker and heat to 70-75° C. Mix phases A and B at 70-75° C.Continue mixing and allow composition to cool to 30° C. Subsequently,add phase C ingredient while mixing. **Any of the active ingredients (orcombination thereof) described in the specification can be used. Forinstance, the active ingredients can include Echinacea purpurea extract,Silybum marianum extract, glycerin, and a mixture comprisingcetylhydroxyproline palmitamide/steric acid/Brassica campestris(rapeseed) sterols. In other aspects, the combination can be Echinaceapurpurea extract, Silybum marianum extract, and cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols. Althoughthe total amount of active ingredients in the Table 1 formulation is 5%w/w, it is contemplated that the amount of active ingredients can beincreased or decreased to achieve a desired result, where the wateramount can be increased/decreased accordingly (e.g., q.s.).

TABLE 2* Ingredient % Concentration (by weight) Phase A Water q.s. to100 M-paraben 0.2 P-paraben 0.1 Na2 EDTA 0.1 Shea butter 4.5 Petrolatum4.5 Glycerin 4.0 Propylene Glycol 2.0 Finsolve TN 2.0 Phase B Sepigel305 2.0 Phase C Active Ingredient(s)** 2.0 *Add ingredients in phase Ato beaker and heat to 70-75° C. while mixing. Subsequently, add thephase B ingredient with phase A and cool to 30° C. with mixing.Subsequently, add phase C ingredient while mixing. **Any of the activeingredients (or combination thereof) described in the specification canbe used. For instance, the active ingredients can include Echinaceapurpurea extract, Silybum marianum extract, rosmarinicacid-α-D-glucoside, glycerin, and a mixture comprisingcetylhydroxyproline palmitamide/steric acid/Brassica campestris(rapeseed) sterols. In other aspects, the combination can be Echinaceapurpurea extract, Silybum marianum extract, and cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols. Althoughthe total amount of active ingredients in the Table 2 formulation is 2%w/w, it is contemplated that the amount of active ingredients can beincreased or decreased to achieve a desired result, where the wateramount can be increased/decreased accordingly (e.g., q.s.).

Example 2 In Vivo Data

In vivo testing was performed using a composition comprising 0.50% byweight of Echinacea purpurea extract, 1.0% by weight of Silybum marianumextract, 2.0% by weight of a mixture comprising cetylhydroxyprolinepalmitamide/steric acid/Brassica campestris (rapeseed) sterols, and15.0% by weight of glycerin. The Echinacea purpurea extract waspurchased from Naturex (France) under the tradename ECHINACEA PURPUREAHERB PE, the Silybum marianum extract was purchased from Provital S.A(SPAIN) under the trade name PRONALEN SILYMARK and the mixturecomprising cetylhydroxyproline palmitamide/steric acid/Brassicacampestris (rapeseed) sterols was purchased from Symrise (Germany) underthe trade name SymRepair®. In particular, a 2 week clinical evaluationfor dryness, texture, and itching was performed using a proprietary baselotion formulation having no preservatives (“Vinny Base”) to whichEchinacea purpurea extract, a Silybum marianum extract, glycerin, and amixture comprising cetylhydroxyproline palmitamide/steric acid/Brassicacampestris (rapeseed) sterols were incorporated. An untreated leg wasused as a control.

Study Design and method: Twenty two (22) female panelists between theages of 18 to 69 years and of Caucasian origin were enrolled in andcompleted the study. Panelists read and signed an informed consent. Thisstudy required 4 visits to the testing facility over a 2 week period.The visits were as follows: Day 0 (baseline), day 2, 7 and 14. Prior toeach measurement, panelists were equilibrated to the testing environmentfor 15 minutes. This study required a one week wash out period prior tothe baseline visit where the panelists were instructed to wash lower legat least two times per day with Ivory® soap bar, using warm water torinse. Panelists were instructed to apply the product on the lowerlateral side of one leg as per treatment randomization code. Theuntreated leg served as control. The results of the study are providedin Tables 1-4.

Visual Grading: During all the visits, panelists were visually graded onthe lower lateral leg by an expert grader for skin texture and skindryness using a Visual Analogue Scale (VAS) (Mild=1-3.9, moderate=4-6.9and severe=7-10) and ordinal scale (0=no evidence of dryness to 4=severeflaking, peeling and/or fissures) respectively.

Subjective Itch Questionnaire: All the panelists were asked to completea subjective itch questionnaire to rate the intensity of their perceivedskin itchiness based on a VAS scale of 0 (none) to 10 (severe) at thebaseline and on day 14 (final) visit only.

Vapometer Measurement: The grading was followed by taking transepidermal water loss (TEWL) measurements using a vapometer.

Product Application: Panelists were instructed to apply the producttwice a day for 2 weeks to the lower lateral area of one leg. Panelistswere asked refrained from extended sun exposure and usage of anymoisturizers, shaving cream and anti-itch products on their legs 1 weekprior to baseline visit until the end of study. They were also asked toabstain from shaving lower legs within forty-eight hours prior to allvisits. They were asked to wash lower legs using Ivory™ soap barapproximately 1 hour prior to each visit.

Statistical Analysis: Changes in visual grading scores and the vapometerdata obtained at days 2, 7 and 14 were compared to baseline using pairedt-test. Statistical significance was considered at p value ≤0.05.

TABLE 3 Expert grading and subjective itch questionnaire for treatmentand control groups Mean Percent Improvement compared to baseline over 2weeks [Percent of panelists showed improvement] Day 2 Day 7 Day 14 SkinAttributes Treated Untreated Treated Untreated Treated Untreated Dryness19%*  NI{circumflex over ( )} 50%*  NI{circumflex over ( )} 69%* NI{circumflex over ( )} [32%]  [NI] [82%]  [NI] [91%]  [NI] Texture24%* NS 47%* 11%* 54%* NS [86%]  [NS] [100%]  [73%]  [100%]  [NS]Itching- NA NA NA NA 64%* NS Subjective [95%]  [NS] questionnaire*Statistically significant compared to baseline at a 95% confidencelevel, {circumflex over ( )}Significantly worse as compared to baseline,NI: No improvement, NS: not significant at 95% confidence level, NA: NotApplicable

TABLE 4 Mean visual grading and subjective itch questionnaire scoresbetween treatment and control groups Mean Scores between treated anduntreated groups over 2 weeks Itching- Skin Dryness Texture Subjectivequestionnaire Attributes Treated Untreated p value Treated Untreated pvalue Treated Untreated p value Baseline 2.09 2.09 1.00 6.66 6.76 0.664.69 5.02 0.14  Day 2 1.66 2.23 0.001^(¥) 5.03 6.37 0.001^(¥) NA NA NADay 7 1.04 2.38 <0.001^(¥) 3.50 5.99 <0.001^(¥) NA NA NA Day 14 0.612.61 <0.001^(¥) 2.96 6.49 <0.001^(¥) 1.54 4.59 <0.001^(¥)^(¥)Statistically significant at a 95% confidence level, NA: NotApplicable

TABLE 5 TEWL analysis for the treatment and control groups as comparedto baseline Mean Percent Improvement compared to baseline over 2 weeksTEWL [Percent of panelists showed improvement] Measurement TreatedUntreated Baseline NS NS [NS] [NS] Day 2 NS NS [NS] [NS] Day 7 NS NS[NS] [NS] Day 14 NS  NI{circumflex over ( )} [NS] [NI] {circumflex over( )}Significantly worse as compared to baseline at a 95% confidenceinterval, NS: not significant at 95% confidence level, NI: noimprovement

TABLE 6 Mean TEWL readings for treatment and control groups TEWL MeanTEWL readings between 2 groups over 2 weeks Measurement TreatedUntreated p value Baseline 5.95 5.99 0.95 Day 2 5.35 5.65 0.67 Day 75.74 6.64 0.11 Day 14 6.17 8.31   0.03 ^(†) ^(†) Statisticallysignificant at a 95% confidence level

The cream significantly improved the skin dryness and skin texture atdays 2, 7 and 14 compared to baseline and untreated group. Untreatedgroup did not show any improvement in skin dryness and texture after 2weeks compared to baseline. Based on self-assessment itch questionnaire,itch intensity showed statistically significant improvement at day 14visit in the treatment group as compared to baseline. However, there wasno significant change in the itch intensity for the untreated groupafter 2 weeks. The anti-itch cream did not significantly improve theskin barrier over 2 weeks in the treatment group as compared tobaseline. However, the anti-itch cream was significantly better atmaintaining the skin barrier at days 7 and 14 compared to the untreatedgroup. The skin barrier significantly worsened in the untreated group at2 weeks compared to baseline.

Example 3 Assays

In addition to the assays mentioned above, the efficacy of thecombination of ingredients disclosed throughout the specification andclaims can be determined by using the following assays.

Erythema Assay: An assay to measure the reduction of skin redness can beevaluated using a Minolta Chromometer. Skin erythema may be induced byapplying a 0.2% solution of sodium dodecyl sulfate on the forearm of asubject. The area is protected by an occlusive patch for 24 hrs. After24 hrs, the patch is removed and the irritation-induced redness can beassessed using the a* values of the Minolta Chroma Meter. The a* valuemeasures changes in skin color in the red region. Immediately afterreading, the area is treated with a composition of the presentinvention. Repeat measurements are taken at regular intervals todetermine the formula's ability to reduce redness and irritation.

Skin Moisture/Hydration Assay: Skin moisture/hydration benefits can bemeasured by using impedance measurements with the Nova Dermal PhaseMeter. The impedance meter measures changes in skin moisture content.The outer layer of the skin has distinct electrical properties. Whenskin is dry it conducts electricity very poorly. As it becomes morehydrated increasing conductivity results. Consequently, changes in skinimpedance (related to conductivity) can be used to assess changes inskin hydration. The unit can be calibrated according to instrumentinstructions for each testing day. A notation of temperature andrelative humidity can also be made. Subjects can be evaluated asfollows: prior to measurement they can equilibrate in a room withdefined humidity (e.g., 30-50%) and temperature (e.g., 68-72° C.). Threeseparate impedance readings can be taken on each side of the face,recorded, and averaged. The T5 setting can be used on the impedancemeter which averages the impedance values of every five secondsapplication to the face. Changes can be reported with statisticalvariance and significance.

Skin Clarity and Reduction in Freckles and Age Spots Assay: Skin clarityand the reduction in freckles and age spots can be evaluated using aMinolta Chromometer. Changes in skin color can be assessed to determineirritation potential due to product treatment using the a* values of theMinolta Chroma Meter. The a* value measures changes in skin color in thered region. This is used to determine whether a composition is inducingirritation. The measurements can be made on each side of the face andaveraged, as left and right facial values. Skin clarity can also bemeasured using the Minolta Meter. The measurement is a combination ofthe a*, b, and L values of the Minolta Meter and is related to skinbrightness, and correlates well with skin smoothness and hydration. Skinreading is taken as above. In one non-limiting aspect, skin clarity canbe described as L/C where C is chroma and is defined as (a²+b2)^(1/2).

Skin Dryness, Surface Fine Lines, Skin Smoothness, and Skin Tone Assay:Skin dryness, surface fine lines, skin smoothness, and skin tone can beevaluated with clinical grading techniques. For example, clinicalgrading of skin dryness can be determined by a five point standardKligman Scale: (0) skin is soft and moist; (1) skin appears normal withno visible dryness; (2) skin feels slightly dry to the touch with novisible flaking; (3) skin feels dry, tough, and has a whitish appearancewith some scaling; and (4) skin feels very dry, rough, and has a whitishappearance with scaling. Evaluations can be made independently by twoclinicians and averaged.

Clinical Grading of Skin Tone Assay: Clinical grading of skin tone canbe performed via a ten point analog numerical scale: (10) even skin ofuniform, pinkish brown color. No dark, erythremic, or scaly patches uponexamination with a hand held magnifying lens. Microtexture of the skinvery uniform upon touch; (7) even skin tone observed withoutmagnification. No scaly areas, but slight discolorations either due topigmentation or erythema. No discolorations more than 1 cm in diameter;(4) both skin discoloration and uneven texture easily noticeable. Slightscaliness. Skin rough to the touch in some areas; and (1) uneven skincoloration and texture. Numerous areas of scaliness and discoloration,either hypopigmented, erythremic or dark spots. Large areas of unevencolor more than 1 cm in diameter. Evaluations were made independently bytwo clinicians and averaged.

Clinical Grading of Skin Smoothness Assay: Clinical grading of skinsmoothness can be analyzed via a ten point analog numerical scale: (10)smooth, skin is moist and glistening, no resistance upon dragging fingeracross surface; (7) somewhat smooth, slight resistance; (4) rough,visibly altered, friction upon rubbing; and (1) rough, flaky, unevensurface. Evaluations were made independently by two clinicians andaveraged.

Skin Smoothness and Wrinkle Reduction Assay With Methods Disclosed inPackman et al. (1978): Skin smoothness and wrinkle reduction can also beassessed visually by using the methods disclosed in Packman et al.(1978). For example, at each subject visit, the depth, shallowness andthe total number of superficial facial lines (SFLs) of each subject canbe carefully scored and recorded. A numerical score was obtained bymultiplying a number factor times a depth/width/length factor. Scoresare obtained for the eye area and mouth area (left and right sides) andadded together as the total wrinkle score.

Skin Firmness Assay with a Hargens Ballistometer: Skin firmness can bemeasured using a Hargens ballistometer, a device that evaluates theelasticity and firmness of the skin by dropping a small body onto theskin and recording its first two rebound peaks. The ballistometry is asmall lightweight probe with a relatively blunt tip (4 square mm-contactarea) was used. The probe penetrates slightly into the skin and resultsin measurements that are dependent upon the properties of the outerlayers of the skin, including the stratum corneum and outer epidermisand some of the dermal layers.

Skin Softness/Suppleness Assay with a Gas Bearing Electrodynamometer:Skin softness/suppleness can be evaluated using the Gas BearingElectrodynamometer, an instrument that measures the stress/strainproperties of the skin. The viscoelastic properties of skin correlatewith skin moisturization. Measurements can be obtained on thepredetermined site on the cheek area by attaching the probe to the skinsurface with double-stick tape. A force of approximately 3.5 gm can beapplied parallel to the skin surface and the skin displacement isaccurately measured. Skin suppleness can then be calculated and isexpressed as DSR (Dynamic Spring Rate in gm/mm).

Appearance of Lines and Wrinkles Assay with Replicas: The appearance oflines and wrinkles on the skin can be evaluated using replicas, which isthe impression of the skin's surface. Silicone rubber like material canbe used. The replica can be analyzed by image analysis. Changes in thevisibility of lines and wrinkles can be objectively quantified via thetaking of silicon replicas form the subjects' face and analyzing thereplicas image using a computer image analysis system. Replicas can betaken from the eye area and the neck area, and photographed with adigital camera using a low angle incidence lighting. The digital imagescan be analyzed with an image processing program and the are of thereplicas covered by wrinkles or fine lines was determined.

Surface Contour of the Skin Assay with a Profilometer/Stylus Method: Thesurface contour of the skin can be measured by using theprofilometer/Stylus method. This includes either shining a light ordragging a stylus across the replica surface. The vertical displacementof the stylus can be fed into a computer via a distance transducer, andafter scanning a fixed length of replica a cross-sectional analysis ofskin profile can be generated as a two-dimensional curve. This scan canbe repeated any number of times along a fix axis to generate a simulated3-D picture of the skin. Ten random sections of the replicas using thestylus technique can be obtained and combined to generate averagevalues. The values of interest include Ra which is the arithmetic meanof all roughness (height) values computed by integrating the profileheight relative to the mean profile height. Rt which is the maximumvertical distance between the highest peak and lowest trough, and Rzwhich is the mean peak amplitude minus the mean peak height. Values aregiven as a calibrated value in mm. Equipment should be standardizedprior to each use by scanning metal standards of know values. Ra Valuecan be computed by the following equation: R_(a)=Standardize roughness;l_(m)=the traverse (scan) length; and y=the absolute value of thelocation of the profile relative to the mean profile height (x-axis).

MELANODERM™ Assay: In other non-limiting aspects, the efficacy of thecompositions of the present invention can be evaluated by using a skinanalog, such as, for example, MELANODERM™. Melanocytes, one of the cellsin the skin analog, stain positively when exposed to L-dihydroxyphenylalanine (L-DOPA), a precursor of melanin. The skin analog, MELANODERM™,can be treated with a variety of bases containing the compositions andwhitening agents of the present invention or with the base alone as acontrol. Alternatively, an untreated sample of the skin analog can beused as a control.

ORAC Assay: Oxygen Radical Absorption (or Absorbance) Capacity (ORAC) ofthe aromatic skin-active ingredients and compositions can also beassayed by measuring the antioxidant activity of such ingredients orcompositions. This assay can quantify the degree and length of time ittakes to inhibit the action of an oxidizing agent such as oxygenradicals that are known to cause damage cells (e.g., skin cells). TheORAC value of the aromatic skin-active ingredients and compositions canbe determined by methods known to those of ordinary skill in the art(see U.S. Publication Nos. 2004/0109905 and 2005/0163880; Cao et al.(1993)), all of which are incorporated by reference). In summary, theassay described in Cao et al. (1993) measures the ability of antioxidantcompounds in test materials to inhibit the decline of B-phycoerythrm(B-PE) fluorescence that is induced by a peroxyl radical generator,AAPH.

Matrix Metalloproteinase Enzyme Activity (MMP3; MMP9) Assay: An in vitromatrix metalloprotease (MMP) inhibition assay. MMPs are extracellularproteases that play a role in many normal and disease states by virtueof their broad substrate specificity. MMP3 substrates include collagens,fibronectins, and laminin; while MMP9 substrates include collagen VII,fibronectins and laminin. Using Colorimetric Drug Discovery kits fromBioMol International for MMP3 (AK-400) and MMP-9 (AK-410), this assay isdesigned to measure protease activity of MMPs using a thiopeptide as achromogenic substrate(Ac-PLG-[2-mercapto-4-methyl-pentanoy]-LG-OC2H5)5,6. The MMP cleavagesite peptide bond is replaced by a thioester bond in the thiopeptide.Hydrolysis of this bond by an MMP produces a sulfhydryl group, whichreacts with DTNB [5,5′-dithiobis(2-nitrobenzoic acid), Ellman's reagent]to form 2-nitro-5-thiobenzoic acid, which can be detected by itsabsorbance at 412 nm (ε=13,600 M−1 cm−1 at pH 6.0 and above 7).

B16 Pigmentation Assay: Melanogenesis is the process by whichmelanocytes produce melanin, a naturally produced pigment that impartscolor to skin, hair, and eyes. Inhibiting melanogenesis is beneficial toprevent skin darkening and lighten dark spots associated with aging.This bioassay utilizes B16-F1 melanocytes (ATCC), an immortalized mousemelanoma cell line, to analyze the effect of compounds on melanogenesis.The endpoint of this assay is a spectrophotometric measurement ofmelanin production and cellular viability. B16-F1 melanocytes, can becultivated in standard DMEM growth medium with 10% fetal bovine serum(Mediatech) at 37° C. in 10% CO₂ and then treated with any one of theactive ingredients, combination of ingredients, or compositions havingsaid combinations disclosed in the specification for 6 days. Followingincubation, melanin secretion was measured by absorbance at 405 nm andcellular viability was quantified.

Collagen Stimulation Assay: Collagen is an extracellular matrix proteincritical for skin structure. Increased synthesis of collagen helpsimprove skin firmness and elasticity. This bioassay can be used toexamine the effect of any one of the active ingredients, combination ofingredients, or compositions having said combinations disclosed in thespecification on the production of procollagen peptide (a precursor tocollagen) by human epidermal fibroblasts. The endpoint of this assay isa spectrophotometric measurement that reflects the presence ofprocollagen peptide and cellular viability. The assay employs thequantitative sandwich enzyme immunoassay technique whereby a monoclonalantibody specific for procollagen peptide has been pre-coated onto amicroplate. Standards and samples can be pipetted into the wells and anyprocollagen peptide present is bound by the immobilized antibody. Afterwashing away any unbound substances, an enzyme-linked polyclonalantibody specific for procollagen peptide can be added to the wells.Following a wash to remove any unbound antibody-enzyme reagent, asubstrate solution can be added to the wells and color develops inproportion to the amount of procollagen peptide bound in the initialstep using a microplate reader for detection at 450 nm. The colordevelopment can be stopped and the intensity of the color can bemeasured. Subconfluent normal human adult epidermal fibroblasts (CascadeBiologics) cultivated in standard DMEM growth medium with 10% fetalbovine serum (Mediatech) at 37° C. in 10% CO₂, can be treated with eachof the combination of ingredients or compositions having saidcombinations disclosed in the specification for 3 days. Followingincubation, cell culture medium can be collected and the amount ofprocollagen peptide secretion quantified using a sandwich enzyme linkedimmuno-sorbant assay (ELISA) from Takara (#MK101).

Tumor Necrosis Factor Alpha (TNF-α) Assay: The prototype ligand of theTNF superfamily, TNF-α, is a pleiotropic cytokine that plays a centralrole in inflammation. Increase in its expression is associated with anup regulation in pro-inflammatory activity. This bioassay can be used toanalyze the effect of any one of the active ingredients, combination ofingredients, or compositions having said combinations disclosed in thespecification on the production of TNF-α by human epidermalkeratinocytes. The endpoint of this assay can be a spectrophotometricmeasurement that reflects the presence of TNF-α and cellular viability.The assay employs the quantitative sandwich enzyme immunoassay techniquewhereby a monoclonal antibody specific for TNF-α has been pre-coatedonto a microplate. Standards and samples can be pipetted into the wellsand any TNF-α present is bound by the immobilized antibody. Afterwashing away any unbound substances, an enzyme-linked polyclonalantibody specific for TNF-α can be added to the wells. Following a washto remove any unbound antibody-enzyme reagent, a substrate solution canbe added to the wells and color develops in proportion to the amount ofTNF-α bound in the initial step using a microplate reader for detectionat 450 nm. The color development can be stopped and the intensity of thecolor can be measured. Subconfluent normal human adult keratinocytes(Cascade Biologics) cultivated in EpiLife standard growth medium(Cascade Biologics) at 37° C. in 5% CO₂, can be treated with phorbol12-myristate 13-acetate (PMA, 10 ng/ml, Sigma Chemical, #P1585-1MG) andany one of the active ingredients, combination of ingredients, orcompositions having said combinations disclosed in the specification for6 hours. PMA has been shown to cause a dramatic increase in TNF-αsecretion which peaks at 6 hours after treatment. Following incubation,cell culture medium can be collected and the amount of TNF-a secretionquantified using a sandwich enzyme linked immuno-sorbant assay (ELISA)from R&D Systems (#DTA00C).

Antioxidant (AO) assay: An in vitro bioassay that measures the totalanti-oxidant capacity of any one of the ingredients, combination ofingredients, or compositions having said combinations disclosed in thespecification. The assay relies on the ability of antioxidants in thesample to inhibit the oxidation of ABTS®(2,2′-azino-di-[3-ethylbenzthiazoline sulphonate]) to ABTS®+ bymetmyoglobin. The antioxidant system of living organisms includesenzymes such as superoxide dismutase, catalase, and glutathioneperoxidase; macromolecules such as albumin, ceruloplasmin, and ferritin;and an array of small molecules, including ascorbic acid, α-tocopherol,β-carotene, reduced glutathione, uric acid, and bilirubin. The sum ofendogenous and food-derived antioxidants represents the totalantioxidant activity of the extracellular fluid. Cooperation of all thedifferent antioxidants provides greater protection against attack byreactive oxygen or nitrogen radicals, than any single compound alone.Thus, the overall antioxidant capacity may give more relevant biologicalinformation compared to that obtained by the measurement of individualcomponents, as it considers the cumulative effect of all antioxidantspresent in plasma and body fluids. The capacity of the antioxidants inthe sample to prevent ABTS oxidation is compared with that of Trolox, awater-soluble tocopherol analogue, and is quantified as molar Troloxequivalents. Anti-Oxidant capacity kit #709001 from Cayman Chemical (AnnArbor, Mich. USA) can be used as an in vitro bioassay to measure thetotal anti-oxidant capacity of each of any one of the activeingredients, combination of ingredients, or compositions having saidcombinations disclosed in the specification. The protocol can befollowed according to manufacturer recommendations. The assay relied onantioxidants in the sample to inhibit the oxidation of ABTS®(2,2′-azino-di-[3-ethylbenzthiazoline sulphonate]) to ABTS®+ bymetmyoglobin. The capacity of the antioxidants in the sample to preventABTS oxidation can be compared with that Trolox, a water-solubletocopherol analogue, and was quantified as a molar Trolox equivalent.

Mushroom tyrosinase activity assay: In mammalian cells, tyrosinasecatalyzes two steps in the multi-step biosynthesis of melanin pigmentsfrom tyrosine (and from the polymerization of dopachrome). Tyrosinase islocalized in melanocytes and produces melanin (aromatic quinonecompounds) that imparts color to skin, hair, and eyes. Purified mushroomtyrosinase (Sigma) can be incubated with its substrate L-Dopa (Fisher)in the presence or absence of each of the active ingredients, any one ofthe combination of ingredients, or compositions having said combinationsdisclosed in the specification. Pigment formation can be evaluated bycolorimetric plate reading at 490 nm. The percent inhibition of mushroomtyrosinase activity can be calculated compared to non-treated controlsto determine the ability of test ingredients or combinations thereof toinhibit the activity of purified enzyme. Test extract inhibition wascompared with that of kojic acid (Sigma).

Cyclooxygenase (COX) Assay: An in vitro cyclooxygenase-1 and -2 (COX-1,-2) inhibition assay. COX is a bifunctional enzyme exhibiting bothcyclooxygenase and peroxidase activities. The cyclooxygenase activityconverts arachidonic acid to a hydroperoxy endoperoxide (ProstaglandinG2; PGG2) and the peroxidase component reduces the endoperoxide(Prostaglandin H2; PGH2) to the corresponding alcohol, the precursor ofprostaglandins, thromboxanes, and prostacyclins. This COX Inhibitorscreening assay measures the peroxidase component of cyclooxygenases.The peroxidase activity is assayed colorimetrically by monitoring theappearance of oxidized N,N,N′,N′-tetramethyl-p-phenylenediamine (TMPD).This inhibitor screening assay includes both COX-1 and COX-2 enzymes inorder to screen isozyme-specific inhibitors. The Colormetric COX (ovine)Inhibitor screening assay (#760111, Cayman Chemical) can be used toanalyze the effects of each of the active ingredients, any one of thecombination of ingredients, or compositions having said combinationsdisclosed in the specification on the activity of purified cyclooxygnaseenzyme (COX-1 or COX-2). According to manufacturer instructions,purified enzyme, heme and test extracts can be mixed in assay buffer andincubated with shaking for 15 min at room temperature. Followingincubation, arachidonic acid and colorimetric substrate can be added toinitiate the reaction. Color progression can be evaluated bycolorimetric plate reading at 590 nm. The percent inhibition of COX-1 orCOX-2 activity can be calculated compared to non-treated controls todetermine the ability of test extracts to inhibit the activity ofpurified enzyme.

Lipoxygenase (LO) Assay: An in vitro lipoxygenase (LO) inhibition assay.LOs are non-heme iron-containing dioxygenases that catalyze the additionof molecular oxygen to fatty acids. Linoleate and arachidonate are themain substrates for LOs in plants and animals. Arachadonic acid may thenbe converted to hydroxyeicosotrienenoic (HETE) acid derivatives, thatare subsequently converted to leukotirenes, potent inflammatorymediators. This assay provides an accurate and convenient method forscreening lipoxygenase inhibitors by measuring the hydroperoxidesgenerated from the incubation of a lipoxygenase (5-, 12-, or 15-LO) witharachidonic acid. The Colorimetric LO Inhibitor screening kit (#760700,Cayman Chemical) can be used to determine the ability of each of theactive ingredients, any one of the combination of ingredients, orcompositions having said combinations disclosed in the specification toinhibit enzyme activity. Purified 15-lipoxygenase and test ingredientscan be mixed in assay buffer and incubated with shaking for 10 min atroom temperature. Following incubation, arachidonic acid can be added toinitiate the reaction and mixtures incubated for an additional 10 min atroom temperature. Colorimetric substrate can be added to terminatecatalysis and color progression was evaluated by fluorescence platereading at 490 nm. The percent inhibition of lipoxyganse activity can becalculated compared to non-treated controls to determine the ability ofeach of the active ingredients, any one of the combination ofingredients, or compositions having said combinations disclosed in thespecification to inhibit the activity of purified enzyme.

Elastase Assay: EnzChek® Elastase Assay (Kit #E-12056) from MolecularProbes (Eugene, Oreg. USA) can be used as an in vitro enzyme inhibitionassay for measuring inhibition of elastase activity for each of theactive ingredients, any one of the combination of ingredients, orcompositions having said combinations disclosed in the specification.The EnzChek kit contains soluble bovine neck ligament elastin that canbe labeled with dye such that the conjugate's fluorescence can bequenched. The non-fluorescent substrate can be digested by elastase orother proteases to yield highly fluorescent fragments. The resultingincrease in fluorescence can be monitored with a fluorescence microplatereader. Digestion products from the elastin substrate have absorptionmaxima at ˜505 nm and fluorescence emission maxima at ˜515 nm. Thepeptide, chloromethyl ketone, can be used as a selective, collectiveinhibitor of elastase when utilizing the EnzChek Elastase Assay Kit forscreening for elastase inhibitors.

Oil Control Assay: An assay to measure reduction of sebum secretion fromsebaceous glands and/or reduction of sebum production from sebaceousglands can be assayed by using standard techniques known to those havingordinary skill in the art. In one instance, the forehead can be used.Each of the active ingredients, any one of the combination ofingredients, or compositions having said combinations disclosed in thespecification can be applied to one portion of the forehead once ortwice daily for a set period of days (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, or more days), while another portion of the foreheadis not treated with the composition. After the set period of daysexpires, then sebum secretion can be assayed by application of fineblotting paper to the treated and untreated forehead skin. This is doneby first removing any sebum from the treated and untreated areas withmoist and dry cloths. Blotting paper can then be applied to the treatedand untreated areas of the forehead, and an elastic band can be placedaround the forehead to gently press the blotting paper onto the skin.After 2 hours the blotting papers can be removed, allowed to dry andthen transilluminated. Darker blotting paper correlates with more sebumsecretion (or lighter blotting paper correlates with reduced sebumsecretion.

All of the skin-active ingredients, compositions, or methods disclosedand claimed in this specification can be made and executed without undueexperimentation in light of the present disclosure. While theskin-active ingredients, compositions, or methods of this invention havebeen described in terms of particular embodiments, it will be apparentto those of skill in the art that variations may be applied to theskin-active ingredients, compositions, or methods and in the steps or inthe sequence of steps of the method described herein without departingfrom the concept, spirit and scope of the invention.

REFERENCES

The following references, to the extent that they provide exemplaryprocedural or other details supplementary to those set forth herein, arespecifically incorporated herein by reference.

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1. A method for moisturizing skin in need thereof, the method comprisingtopically applying to the skin a composition that includes effectiveamounts of an extract from Echinacea purpurea, an extract from Silybummarianum, and glycerin, wherein topical application of the compositionactivates human cannabinoid receptor type 2 and inhibits fatty acidamide hydrolase activity in the skin and treats the skin.
 2. The methodof claim 1, wherein the composition further comprises water and sodiumhyaluronate.
 3. The method of claim 2, wherein the composition furthercomprises butylene glycol, glycereth-26, squalane, lecithin, glycine,tocopheryl acetate, xanthan gum, hydroxyethylcellulose, andphenoxyethanol.
 4. The method of claim 1, wherein the composition is acream or lotion.
 5. The method of claim 1, wherein the composition is anemulsion.
 6. The method of claim 5, wherein the emulsion is anoil-in-water emulsion.
 7. The method of claim 1, wherein the effectiveamount of the extract from Echinacea purpurea is 0.001 to 10% by weightof the composition and the effective amount of the extract from Silybummarianum is 0.001 to 10% by weight of the composition.
 8. The method ofclaim 1, wherein the applied composition remains on the skin for atleast 5 minutes after topical application.
 9. The method of claim 1,wherein the composition is comprised in a mask.
 10. The method of claim1, wherein the skin in need thereof is dry skin.
 11. The method of claim1, wherein the skin in need thereof is erythemic skin.
 12. The method ofclaim 1, wherein the skin in need thereof is facial skin.
 13. The methodof claim 1, wherein the Echinacea purpurea extract and the Silybummarianum extract are each aqueous, alcoholic, or hydro-alcoholicextracts.
 14. The method of claim 1, wherein the composition furthercomprises a UV absorbing agent, an anti-oxidant, a structuring agent, anemulsifier, a silicone containing compound, an essential oil, athickening agent, or a preservative.